FlexED: En digital, gamifierad tidig intervention för ätstörningar
The goal of this clinical trial is to test a new intervention for body-image distress to reduce eating disorder symptoms in young women and girls between the ages of 15-25 years old.
Participants complete up to 8 digital sessions using their mobile phone that include a character, story line and interactive exercises, games and digital rewards. Everyone in the study completes the intervention after different periods of time (2, 4 or 6 weeks) of completing assessments.
Researchers will examine the impact of the intervention on participants ability to respond flexibly to body-image distress or triggers, measuring things like heart rate, eye gaze, and reaction time to body-image related words and images, and test how long it takes to see change.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This multiple baseline experiment tests the impact of a digital, gamified early intervention for eating disorders on body-image psychological flexibility and assesses treatment dose. Twenty-four young women and girls with eating disorder (ED) symptoms are randomized to baseline duration between 2-6 weeks. Participants complete up to eight 20-30 minute sessions of a multimedia application using their mobile phone. Psychological flexibility is measured repeatedly using a multi-level, multi-dimensional assessment strategy of self-report and lab-based tasks assessing flexibility in cognition, affect and attention with body-image related stimuli during the baseline and treatment phases to estimate treatment effects.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
North Carolina
-
Durham, North Carolina, Förenta staterna, 27705
- Duke University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Female identified 15-25 years old
- Weight Concerns Scale score of >47
- Eating disorder behaviors with onset at current level <3 years
Exclusion Criteria:
- Currently meet diagnostic criteria for anorexia or bulimia nervosa
- Psychosis, substance use disorder or current suicidal ideation or self-harm.
- Start or change in psychiatric medications within the past month.
- NonEnglish Speaking.
- Presents with other specified feeding or eating disorder (OSFED) that does not includes weight/shape concerns as a primary feature (e.g., Avoidant Restrictive Food Intake Disorder).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 2-Week Baseline Duration
2 weeks of assessment, then 8 weeks of intervention |
Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises. |
|
Experimentell: 4-Week Baseline Duration
4 weeks of assessment, then 8 weeks of intervention |
Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises. |
|
Experimentell: 6-Week Baseline Duration
6 weeks of assessment, then 8 weeks of intervention |
Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises. |
|
Experimentell: Condensed schedule
2 weeks of assessment, then 4 weeks of intervention (sessions twice a week) |
Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5)
Tidsram: Baseline, 6-8 weeks and 12 weeks
|
5-item measure assessing the ability to behave flexibly in the presence of negative thoughts and feelings about the body. Scores range from 5 to 35 with higher scores indicating greater flexibility. |
Baseline, 6-8 weeks and 12 weeks
|
|
High Frequency Heart Rate Variability (HF-HRV)
Tidsram: Baseline, 6-8 weeks, and 12 weeks
|
Heart rate variability during provocation of body image distress; greater variability indicates an increased capacity to modulate arousal and distress. Indexed by HF Power ms^2 (Induction-Rest). |
Baseline, 6-8 weeks, and 12 weeks
|
|
Change From Baseline in Biased Processing of Body Image Stimuli Relative to Neutral Stimuli
Tidsram: Baseline, 6-8 weeks, and 12 weeks
|
Biased processing of stimuli is assessed using an emotional Stroop task with body image and neutral stimuli. Improvements are indicated by decreases in bias score (decreases in difference in reaction time between evocative and neutral stimuli). |
Baseline, 6-8 weeks, and 12 weeks
|
|
CompACT-10 (Comprehensive Assessment of Acceptance and Commitment Therapy)
Tidsram: Baseline, 6-8 weeks, 12 weeks
|
10-item measure assessing psychological flexibility. Total scores range from 10 to 70 with higher scores indicating greater flexibility. |
Baseline, 6-8 weeks, 12 weeks
|
|
Number of Eye Gaze Fixations on Pathology-relevant, Body-image Stimuli
Tidsram: Baseline, 6-8 weeks, 12 weeks
|
Number of fixations on body and food related images presented during HF-HRV task. |
Baseline, 6-8 weeks, 12 weeks
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro00111571
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